{ENGLISH} CHAPTER 1 PHARMACEUTICAL MANUFACTURE FACILITIES – PART 3 (END)

CHAPTER 1 PHARMACEUTICAL MANUFACTURE FACILITIES – PART 3 (END)

 

Drug Product Manufacture Facility

For the manufacture facility, drugs can be divided into sterile products (Injection, Eye Drop, Eye ointment, Nasal drops) and non-sterile products (Tablet, capsule, powder, liquid (Oral Solid Dosage), Lotion, Ointment, (External drug)).

Manufacture of Sterile Products – the Injections

Injections are directly administrated into the human body by doctors or nurses in principle. Since active ingredients will not be eliminated by digestive organs and liver, injections can be expected for a straight effect. On the other hand, if any contaminations occur, injections have a greater risk of causing health damage than oral dosage for not passing the digestive system in the body, which is regarded as a filter. Furthermore, it is difficult to confirm an injection product contaminated by microorganisms visually. It is also necessary to eliminate the substance responsible for fever, called pyrogen.

The typical substance of pyrogen is endotoxin-like β peptide glycan, which is the component of the dead bacteria cell wall. It is said that endotoxin is one of the causes of fever when we catch a cold. So, in the manufacturing process of injections, special cares have to be taken. The special cares are sterilization and de-pyrogenation (removal of pyrogen). The injection is the most typical product in terms of sterile pharmaceuticals, which should be manufactured at appropriate facilities to minimize the risks of microbial particulate, foreign matter, and pyrogenic contamination.

Special care to Sterility

Injections are manufactured by steps like these: dissolved API and excipients into water, then aseptic filtration to remove microorganisms, followed by filling into containers, sealing, and packing into a box.…